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usp-1121-bulk-pharmaceutical-chemicals-and-impurity-handling
Impurity Profiling EMA Guideline on Genotoxic Impurities in PharmaceuticalsEMA Reflection Paper on Low Level ImpuritiesFDA Guidance: Microbial Impurities and Endotoxin LevelsFDA Guidance: Threshold of Toxicological Concern (TTC) for ImpuritiesFDA ICH M3(R2): Impurities in Safety StudiesFDA Q&A on Impurities in Generic Drug ApplicationsFDA Q&A: Managing Impurities in Complex APIsICH E14: QT Interval Evaluation and Impurity ImpactICH M7: Mutagenic Impurity Risk AssessmentICH Q10: Pharmaceutical Quality System for Impurity ManagementICH Q11: Impurity Control Strategy in Drug Substance DevelopmentICH Q12: Lifecycle Management of Impurity Control StrategyICH Q1E: Evaluation of Stability Data Related to Impurity FormationICH Q2(R1): Validation of Analytical Methods for Impurity TestingICH Q3A: Organic Impurity Profiling in Drug SubstancesICH Q3B: Impurity Testing in Finished Drug ProductsICH Q3C: Residual Solvent ProfilingICH Q3D: Elemental Impurity Risk AssessmentICH Q3F: Impurity Guidelines for Biotechnology ProductsICH Q4B: Harmonization of Analytical Procedures for Impurity TestingICH Q5C: Impurity Monitoring in Biotechnological ProductsICH Q6A: Specifications and Acceptance Criteria for ImpuritiesICH S3A: Impurities Arising from Degradation ProductsICH S6: Biotech Product Impurity ProfilingICH S7A: Safety Pharmacology Impurity EvaluationICH S9: Impurities in Oncology ProductsISO 10993-18: Chemical Characterization and Impurity AnalysisISO 17025: Accreditation for Impurity Testing LaboratoriesJP General Rule 2.60: Limit Test for ImpuritiesPh. Eur. 2.2.28: Gas Chromatography for Impurity DetectionPh. Eur. 2.2.38: Thin-Layer Chromatography for ImpuritiesPh. Eur. 2.2.46: Chromatographic Separation for Impurity AnalysisPh. Eur. 2.4.14: Determination of Inorganic ImpuritiesPh. Eur. 2.4.20: Limit Test for Heavy Metals in ImpuritiesPh. Eur. 2.4.24: Related Substances by HPLC in APIsPh. Eur. 2.4.29: Limit Test for Sulfated Ash ImpuritiesPh. Eur. 2.5.13: Oxidizing Impurity TestsPh. Eur. 2.9.40: Uniformity of Dosage Units and Related ImpuritiesPh. Eur. 5.10: Control of Impurities in Substances for Pharmaceutical UsePh. Eur. 5.4: Impurities in Radiopharmaceutical PreparationsUSP <1010>: Analytical Data Integrity in Impurity ReportingUSP <1031>: The Biocompatibility of Materials and ImpuritiesUSP <1051>: Cleaning Validation Limits and Residual ImpuritiesUSP <1058>: Analytical Instrument Qualification for Impurity StudiesUSP <1078>: Good Manufacturing Practices for Impurity ReductionUSP <1085>: Evaluation of Impurity Method PerformanceUSP <1086>: Impurities in Drug SubstancesUSP <1088>: Forced Degradation Studies for Impurity CharacterizationUSP <1091>: Impurity Isolation and Characterization TechniquesUSP <1099>: Acceptable Analytical Performance CriteriaUSP <1151>: Pharmaceutical Dosage Forms and Impurity ConsiderationUSP <1191>: Stability Testing of Compounded PreparationsUSP <1222>: Terminal Sterilization Impact on ImpuritiesUSP <1224>: Transfer of Impurity Test ProceduresUSP <1225>: Validation of Compendial Procedures for ImpuritiesUSP <1226>: Verification of Compendial Procedures for Impurity DetectionUSP <1231>: Water for Pharmaceutical Purposes and Impurity EffectsUSP <1232>: Water Activity and Impurity StabilityUSP <1241>: Capsules and Shell Impurity InteractionUSP <1251>: Weighing on Analytical Balances for Micro-ImpuritiesUSP <161>: Transdermal Delivery Systems and Impurity ControlUSP <197>: Spectrophotometric Identification of ImpuritiesUSP <233>: Elemental Impurities Profiling Using ICP-MSUSP <41>: Balances Used for Impurity Weight DeterminationUSP <466>: Identification and Quantification of DegradantsUSP <467>: Residual Solvent Testing in APIs and ExcipientsUSP <476>: Impurity Profiling for New Drug ApplicationsUSP <621>: Chromatography Conditions for Impurity IdentificationUSP <730>: Plasma Spectrochemistry for Impurity ProfilingUSP <791>: pH Determination Impact on Impurity SolubilityUSP <797>: Sterile Compounding and Impurity ControlUSP <800>: Hazardous Drug Handling Based on Impurity RiskUSP <851>: Spectrophotometry and Light Scattering for ImpuritiesUSP <853>: Atomic Absorption Spectroscopy for Trace ImpuritiesUSP <857>: UV-Vis Spectroscopy for Impurity QuantificationUSP <85>: Bacterial Endotoxin Limits Related to Impurity SafetyUSP <891>: Nuclear Magnetic Resonance (NMR) for Structural ElucidationUSP <905>: Content Uniformity Related to ImpuritiesUSP <905>: Uniformity of Dosage Units Affected by ImpuritiesUSP <941>: Characterization of Impurity Solubility and pKaWHO TRS 970 Annex 2: Impurity Control in Medicines

Comprehensive Guide to USP <1121>: Bulk Pharmaceutical Chemicals and Impurity Handling Laboratory Testing Service Provided by Eurolab

USP <1121> is a comprehensive standard that outlines the requirements for testing bulk pharmaceutical chemicals and impurities. This standard is developed and published by the United States Pharmacopeia (USP), an independent, non-profit organization that sets standards for the quality of pharmaceuticals.

Legal and Regulatory Framework

The legal and regulatory framework surrounding USP <1121> testing is governed by various international and national standards. These include:

  • ISO 9001:2015, Quality Management Systems - Requirements

  • ASTM E2533-10, Standard Practice for Validation of Analytical Methods

  • EN 14146:2004, Pharmacopoeial Harmonization, Bulk Pharmaceutical Excipients, General Chapters

  • TSE (Turkish Standards Institution) GOST R ISO 9001-2015, Quality Management Systems - Requirements

    • International and National Standards

    The following international and national standards apply to USP <1121> testing:

  • International Standards:

    • ISO 13485:2016, Medical Devices Quality Management Systems Requirements for Regulatory Purposes

    ICH Q7, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (APIs)

  • National Standards:

    • EU GMP (Good Manufacturing Practice) Regulations, Annex 1 to Part III of the European Pharmacopoeia

    US FDA Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations

    Standard Development Organizations

    The following standard development organizations play a crucial role in the development and maintenance of standards related to USP <1121> testing:

  • United States Pharmacopeia (USP)

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

    • Evolution and Updates

    Standards evolve and get updated periodically to reflect changes in technology, regulatory requirements, or industry practices. Eurolab ensures that our testing services are aligned with the latest standards and regulations.

    Standard Numbers and Scope

    The following standard numbers and their scope apply to USP <1121> testing:

  • ISO 9001:2015, Quality Management Systems - Requirements

    • Applies to all organizations involved in pharmaceuticals manufacturing

  • ASTM E2533-10, Standard Practice for Validation of Analytical Methods

    • Applies to analytical methods used in pharmaceuticals testing

  • EN 14146:2004, Pharmacopoeial Harmonization, Bulk Pharmaceutical Excipients, General Chapters

    • Applies to bulk pharmaceutical excipients and general chapters

    Standard Compliance Requirements

    Compliance with USP <1121> standards is mandatory for all organizations involved in pharmaceuticals manufacturing. Eurolab ensures that our testing services meet these compliance requirements.

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    Why this specific test is needed and required

    USP <1121> testing is essential to ensure the quality, safety, and efficacy of bulk pharmaceutical chemicals and impurities. This standard requires testing for various parameters, including identity, purity, potency, and impurities.

    Business and Technical Reasons for Conducting USP <1121> Testing

    Conducting USP <1121> testing is crucial from both business and technical perspectives:

  • Business: Compliance with regulatory requirements and standards ensures customer confidence and trust.

  • Technical: Accurate testing ensures the quality, safety, and efficacy of pharmaceuticals.

    • Consequences of Not Performing this Test

    Failure to conduct USP <1121> testing can result in:

  • Regulatory non-compliance

  • Product contamination or adulteration

  • Customer dissatisfaction and loss of business

    • Industries and Sectors that Require this Testing

    The following industries and sectors require USP <1121> testing:

  • Pharmaceutical manufacturing

  • Biotechnology

  • Cosmetics and personal care products

  • Food and beverage industry

    • Risk Factors and Safety Implications

    USP <1121> testing is critical to mitigate risks associated with pharmaceuticals, including:

  • Contamination or adulteration of products

  • Adverse reactions or toxicity due to impurities

  • Loss of product efficacy due to incorrect formulation or impurities

    • Quality Assurance and Quality Control Aspects

    Eurolab ensures that our USP <1121> testing services meet the highest quality assurance and control standards, including:

  • ISO 9001:2015, Quality Management Systems - Requirements

  • ASTM E2533-10, Standard Practice for Validation of Analytical Methods

    • Contribution to Product Safety and Reliability

    USP <1121> testing contributes significantly to product safety and reliability by ensuring the accuracy and precision of analytical results.

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    Detailed Step-by-Step Explanation of How the Test is Conducted

    Eurolabs USP <1121> testing services are conducted in accordance with the standards requirements, including:

  • Sample preparation

  • Instrument calibration and validation

  • Testing for various parameters, including identity, purity, potency, and impurities

    • Sample Preparation

    Eurolab ensures that all samples are prepared according to the standards requirements, including:

  • Weighing and dilution of samples

  • Homogenization and mixing of samples

    • Instrument Calibration and Validation

    Eurolab ensures that our instruments are calibrated and validated according to the standards requirements, including:

  • Regular calibration and maintenance of equipment

  • Validation of analytical methods using certified reference materials (CRMs)

    • Testing for Various Parameters

    Eurolab tests for various parameters, including:

  • Identity: testing for the presence or absence of specific substances

  • Purity: testing for impurities and contaminants

  • Potency: testing for the strength or activity of a substance

  • Impurities: testing for the presence or absence of specific impurities

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    Conclusion

    In conclusion, USP <1121> testing is essential to ensure the quality, safety, and efficacy of bulk pharmaceutical chemicals and impurities. Eurolabs comprehensive guide provides an overview of the standards requirements, including the legal and regulatory framework, international and national standards, standard development organizations, evolution and updates, standard numbers and scope, standard compliance requirements, business and technical reasons for conducting USP <1121> testing, consequences of not performing this test, industries and sectors that require this testing, risk factors and safety implications, quality assurance and control aspects, contribution to product safety and reliability, detailed step-by-step explanation of how the test is conducted, sample preparation, instrument calibration and validation, and testing for various parameters.

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